Cleared Traditional

DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEM (K964922) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K964922 · Althin Medical AB an Affiliate of Baxter Intl · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
163d
Days
Class 2
Risk

K964922 is an FDA 510(k) clearance for the DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE.... Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Althin Medical AB an Affiliate of Baxter Intl (Portland, US). The FDA issued a Cleared decision on May 21, 1997 after a review of 163 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Althin Medical AB an Affiliate of Baxter Intl devices

Submission Details

510(k) Number K964922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1996
Decision Date May 21, 1997
Days to Decision 163 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 130d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

All 343
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K964922.
NxStage System One with NxView
K252377 · Fresenius Medical Care Renal Therapies Group, LLC · May 2026
ELISIO™-H
K260533 · Nipro Medical Corporation · Mar 2026
multiFlux 130 (F00013123)
K252459 · Fresenius Medical Care Renal Therapies Group, LLC · Feb 2026
Tablo Hemodialysis System (PN-0008000, PN-0006000U)
K253412 · Outset Medical, Inc. · Jan 2026
FX CorAL 40
K253518 · Fresenius Medical Care Renal Therapies Group, LLC · Dec 2025
Purema H Hemoconcentrator - Pediatric
K243920 · Medica USA, Inc. · Sep 2025